Active Clinical Trials

Active Trials for May 2025

Neuro-Oncology Clinical Trials – Summary

Saint John’s Cancer Institute is enrolling patients in a variety of neuro-oncology clinical trials targeting gliomas, glioblastomas, CNS lymphomas, and chordomas. These studies investigate novel therapies such as ONC201, NanO2™, ketogenic diets, CA-4948, and immunotherapy combinations. Trials are sponsored by leading biotech firms and academic institutions, with eligibility based on tumor type, genetic mutations, prior treatments, and performance status.

Key Neuro-Oncology Trials

• ONC201 for H3 K27M-mutant Diffuse Glioma
  • Sponsor: Chimerix
  • PI: Dr. Naveed Wagle
  • Indication: Newly diagnosed H3 K27M-mutant glioma
  • Eligibility: Completed radiation within 6 weeks; no adjuvant TMZ; non-pontine or leptomeningeal tumors
  • Status: On hold
  • NCT05580562
• Expanded Access to ONC201 for Midline Gliomas
  • Sponsor: Chimerix
  • PI: Dr. Naveed Wagle
  • Indication: DIPG, spinal gliomas, leptomeningeal disease
  • Eligibility: 14–90 days post-radiation; no prior ONC201/206 unless non-Chimerix; bevacizumab allowed
  • NCT04617002
• RESTORE Study: NanO2™ + Radiation + Temozolomide for Glioblastoma
  • Sponsor: NuvOx
  • PI: Dr. Naveed Wagle
  • Indication: Newly diagnosed glioblastoma
  • Eligibility: Histologically confirmed; planned 60 Gy radiation with temozolomide; KPS ≥ 70
  • NCT03862430
• Ketogenic Diet vs Standard Diet in Glioblastoma
  • Sponsor: Cedars-Sinai Medical Center
  • PI: Dr. Naveed Wagle
  • Indication: Newly diagnosed glioblastoma
  • Eligibility: Within 2 months of diagnosis; no prior chemo/radiation; no lipid metabolism disorders
  • NCT05708352
• CA-4948 in Refractory Primary CNS Lymphoma
  • Sponsor: Curis
  • PI: Dr. Naveed Wagle
  • Indication: Relapsed/refractory primary CNS lymphoma
  • Eligibility: No isolated intraocular PCNSL; BTKi-naive or experienced; KPS ≥ 60; ECOG 0–2
  • NCT03328078
• Pembrolizumab + High-Dose Pemetrexed for Chordoma
  • Sponsor: Saint John’s Cancer Institute (local study)
  • PI: Dr. Naveed Wagle
  • Indication: Progressive chordoma
  • Eligibility: Progression within 6 months; ECOG 0–1; no chronic steroids >10 mg prednisone
  • NCT06794645

Prostate Cancer Clinical Trials – Summary

Saint John’s Cancer Institute is actively enrolling patients in several prostate cancer clinical trials, ranging from early-stage to metastatic disease. These studies explore novel immunotherapies, radiopharmaceuticals, diagnostic imaging, and hormonal therapies. Trials are sponsored by leading pharmaceutical companies and research groups, with eligibility based on disease stage, prior treatments, and genetic markers such as HRRm mutations.

Key Prostate Cancer Trials

• REGN5678 ± Cemiplimab in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Sponsor: Regeneron
  • PI: Dr. Przemyslaw Twardowski
  • Indication: mCRPC and other PSMA-expressing tumors
  • Eligibility: ≥2 prior therapies; specific criteria for ccRCC; post-177Lu-PSMA-617 cohort requires ≥2 doses
  • Status: No slots open
  • NCT03972657
• AZD5305 + Hormonal Agents in HRRm and non-HRRm mCSPC (EvoPARProstate01)
  • Sponsor: AstraZeneca
  • PI: Dr. Przemyslaw Twardowski
  • Indication: Metastatic castration-sensitive prostate cancer (mCSPC)
  • Eligibility: HRRm mutation required; excludes prior PARP inhibitor or platinum chemo; ECOG 0–1
  • NCT06120491
• Copper Cu 64 PSMA I&T PET/CT for Staging Prostate Cancer
  • Sponsor: Curium
  • PI: Dr. Przemyslaw Twardowski
  • Indication: Newly diagnosed, high-risk prostate cancer
  • Eligibility: Must be planning radical prostatectomy with ePLND; no prior ADT or PET-PSMA within 90 days
  • NCT06235151
• Long-Term Safety of 177Lu-vipivotide tetraxetan (AAA617)
  • Sponsor: Novartis
  • PI: Dr. Przemyslaw Twardowski
  • Indication: Prostate cancer patients previously treated with AAA617 in Novartis trials
  • Eligibility: Must have received AAA617 in a prior trial; condom use required for 14 weeks post-treatment
  • NCT05803941

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  Non-Prostate Genitourinary Clinical Trials – Summary

  This section includes trials for bladder cancer, focusing on novel intratumoral therapies. These studies are designed for patients undergoing surgery and exclude those with metastatic disease or autoimmune conditions.

  Key Non-Prostate Genitourinary Trials

  • AU-011 Intratumoral Injection in Bladder Cancer
    • Sponsor: Aura Biosciences, Inc.
    • PI: Dr. Jennifer Linehan
    • Indication: NMIBC or MIBC with planned TURBT or cystectomy
    • Eligibility: No metastatic disease, autoimmune conditions, or coagulation issues; no active malignancies requiring treatment
    • Status: Enrollment paused
    • NCT05483868

  Melanoma Clinical Trials – Summary

  Saint John’s Cancer Institute is conducting several melanoma trials, including perioperative immunotherapy, biomarker-driven studies, and expanded access programs. These trials target both early-stage and advanced melanoma, with a focus on checkpoint inhibitors and novel combinations.

  Key Melanoma Trials

  • DECIDE: DecisionDx Impact on SLNB Decisions
    • Sponsor: Castle Biosciences, Inc.
    • PI: Dr. Richard Essner
    • Indication: Newly diagnosed cutaneous melanoma
    • Eligibility: Within 2 months of biopsy; excludes Stage III/IV or prior melanoma in same region
    • [NCT not listed]
  • Fianlimab + Cemiplimab vs Anti-PD1 Alone in Resectable Stage III/IV Melanoma
    • Sponsor: Regeneron
    • PI: Dr. Kim Margolin
    • Indication: Resectable Stage IIIB–IV melanoma
    • Eligibility: ECOG 0–1; measurable disease per RECIST; excludes Stage IIIA and M1d
    • Status: Enrollment paused
    • NCT06190951
  • IMC-F106C + Nivolumab vs Nivolumab Alone in Advanced Melanoma (PRISM-MEL-301)
    • Sponsor: Immunocore
    • PI: Dr. Kim Margolin
    • Indication: Previously untreated, unresectable or metastatic melanoma
    • Eligibility: HLA-A*02:01 positive; ECOG 0–1; measurable disease; prior adjuvant therapy allowed
    • NCT061123141
  • Fianlimab + Cemiplimab vs Relatlimab + Nivolumab in Unresectable/Metastatic Melanoma
    • Sponsor: Regeneron
    • PI: Dr. Kim Margolin
    • Indication: Unresectable or metastatic melanoma
    • Eligibility: No prior systemic therapy for advanced disease; no prior checkpoint inhibitors except anti-PD1/PD-L1
    • NCT06246916
  • Expanded Access: VO + Nivolumab in Advanced Melanoma Post Anti-PD1 Therapy
    • Sponsor: Replimune
    • PI: Dr. Kim Margolin
    • Indication: Advanced melanoma progressed on anti-PD1
    • Eligibility: ≥1 injectable lesion ≥1 cm; excludes >2 prior systemic therapies or prior intratumoral therapy
    • NCT06590480

  Breast Cancer Clinical Trials – Summary

  Saint John’s Cancer Institute offers a wide range of breast cancer clinical trials, including studies on triple-negative breast cancer (TNBC), HER2-positive disease, hormone receptor-positive cancers, and cognitive effects of treatment. These trials explore de-escalation strategies, novel drug combinations, imaging techniques, and supportive care interventions.

  Key Breast Cancer Trials

  • OptimICE-PCR: De-escalation in Early-Stage TNBC with pCR
    • Sponsor: Cooperative Group Alliance
    • PI: Dr. Parvin Peddi
    • Indication: TNBC with no residual invasive disease after neoadjuvant chemo + pembrolizumab
    • Eligibility: Residual DCIS allowed; ≥6 cycles of neoadjuvant therapy
    • NCT05812807
  • A191901: Optimizing Endocrine Therapy via Text and Interview
    • Sponsor: Cooperative Group Alliance
    • PI: Dr. Janie Grumley
    • Indication: Stage I–III HR+ HER2- breast cancer
    • Eligibility: Must be on or starting endocrine therapy; no prior cancer history
    • NCT04379570
  • NRG-C011: Cognitive Training for Cancer-Related Impairment
    • Sponsor: Cooperative Group Alliance
    • PI: Dr. Janie Grumley
    • Indication: Stage I–III non-metastatic breast cancer
    • Eligibility: PROMIS score <12; 6 months–5 years post-treatment
    • NCT05896189
  • TailorRT: Regional Radiotherapy in Biomarker Low-Risk Node-Positive Breast Cancer
    • Sponsor: CCTG
    • PI: Dr. Janie Grumley
    • Indication: Non-metastatic invasive carcinoma with Oncotype DX ≤25
    • Eligibility: T3N0, ER ≥1%, HER2-negative
    • NCT03488693
  • DIRECT Trial: FDG-PET/CT for HER2+ Neoadjuvant Therapy Response
    • Sponsor: ECOG-ACRIN
    • PI: Dr. Parvin Peddi
    • Indication: HER2+ breast cancer, Stage IIa–IIIc
    • Eligibility: Known hormone receptor status; histologically confirmed
    • NCT05710328
  • Bria-IMT + Checkpoint Inhibitor vs Physician’s Choice in Metastatic Breast Cancer
    • Sponsor: BriaCell Therapeutics
    • PI: Dr. Parvin Peddi
    • Indication: Advanced MBC with no meaningful alternatives
    • Eligibility: Persistent or metastatic disease; failed all approved regimens
    • NCT06072612
  • Perioperative Pain Management in Oncoplastic Breast Surgery
    • Sponsor: SJCI (local study)
    • PI: Dr. Janie Grumley
    • Indication: Breast cancer patients undergoing surgery
    • Eligibility: All patients presenting for initial surgical treatment
    • [NCT not listed]
  • Inavolisib + Phesgo vs Placebo + Phesgo in PIK3CA-Mutated HER2+ mBC
    • Sponsor: Hoffman-La Roche
    • PI: Dr. Reva Basho
    • Indication: PIK3CA-mutated HER2+ metastatic breast cancer
    • Eligibility: Confirmed HER2+ and PIK3CA mutation
    • NCT05894239
  • Fulvestrant + Binimetinib in HR+ MBC with NF1 Alterations (ComboMATCH)
    • Sponsor: National Cancer Institute (NCI)
    • PI: Dr. Reva Basho
    • Indication: HR+ MBC with NF1 mutations
    • Eligibility: Prior CDK4/6 inhibitor; up to one line of chemo in metastatic setting
    • Status: Appears closed
    • NCT05554354
  • BNT327-02: BNT327 + Chemo in TNBC (1st/2nd Line)
    • Sponsor: BioNTech SE
    • PI: Dr. Parvin Peddi
    • Indication: Locally recurrent or metastatic TNBC
    • Eligibility: Up to one prior systemic therapy; ECOG 0–1
    • NCT06449222

  Other Solid Tumors Clinical Trials – Summary

  These trials target a broad range of advanced or metastatic solid tumors, including MSI-H, TMB-H, and AKT-altered cancers. They explore immunotherapies, IL-2 superkines, and targeted agents in combination with chemotherapy.

  Key Other Solid Tumor Trials

  • BI 1831169 ± Ezabenlimab in Advanced Solid Tumors
    • Sponsor: Boehringer Ingelheim
    • PI: Dr. Naveed Wagle
    • Indication: Metastatic or recurrent solid tumors
    • Eligibility: At least one injectable lesion ≥10 mm; ECOG 0–1; no brain metastases or steroid use
    • Status: Waitlist
    • NCT05155332
  • MDNA11 ± Checkpoint Inhibitor in Advanced Solid Tumors
    • Sponsor: Medicenna
    • PI: Dr. Przemyslaw Twardowski
    • Indication: MSI-H, dMMR, TMB-H, melanoma, NMSC, or other IL-2/IO-sensitive tumors
    • Eligibility: ECOG 0–1; no high-dose steroids; stable/treated brain metastases allowed
    • NCT05086692
  • Paclitaxel + Ipatasertib in AKT-Altered Non-Breast Solid Tumors (ComboMATCH)
    • Sponsor: National Cancer Institute (NCI)
    • PI: Dr. Reva Basho
    • Indication: Advanced non-breast solid tumors with AKT alterations
    • Eligibility: Progressed within 6 months of taxane-based therapy
    • NCT05554380

  Have questions?

  For more information about any of our clinical trials, or general questions, please call our main hotline.   See Clinical Trials FAQs for additional information.

  Please call, 310-582-7448 to participate in a clinical trial

  The clinical trials listed below represent active and enrolling trials. We implement, initiate, and oversee clinical trials here, at Saint John’s Cancer Institute, as well as other facilities in the Southern California region.

  Search using key terms or filter by Centers of Excellence or by Lead Doctor.